Ertugliflozin plus sitagliptin versus either individual agent over 52 weeks in patients with type 2 diabetes mellitus inadequately controlled with metformin: The VERTIS FACTORIAL randomized trial

Autor: Gregory T. Golm, Roy Eldor, Annaswamy Raji, Yanping Qiu, Susan Huyck, James P. Mancuso, Sheila Sunga, Steven G. Terra, Brett Lauring, Jeremy Johnson, Samuel S. Engel, Richard E. Pratley
Rok vydání: 2017
Předmět:
Male
Endocrinology
Diabetes and Metabolism

Drug Resistance
Type 2 diabetes
030204 cardiovascular system & hematology
Gastroenterology
law.invention
Body Mass Index
0302 clinical medicine
Endocrinology
DPP‐IV inhibitor
Randomized controlled trial
law
Clinical endpoint
integumentary system
clinical trial
SGLT2 inhibitor
Middle Aged
Metformin
glycaemic control
Sitagliptin
Drug Therapy
Combination

Female
Original Article
type 2 diabetes
medicine.drug
medicine.medical_specialty
030209 endocrinology & metabolism
03 medical and health sciences
Double-Blind Method
Internal medicine
Internal Medicine
medicine
Humans
Hypoglycemic Agents
Adverse effect
Sodium-Glucose Transporter 2 Inhibitors
Aged
Glycated Hemoglobin
Dipeptidyl-Peptidase IV Inhibitors
Dose-Response Relationship
Drug

business.industry
Sitagliptin Phosphate
Type 2 Diabetes Mellitus
Original Articles
Overweight
medicine.disease
Bridged Bicyclo Compounds
Heterocyclic

Hypoglycemia
phase III study
stomatognathic diseases
Blood pressure
Diabetes Mellitus
Type 2

Hyperglycemia
business
Follow-Up Studies
Zdroj: Diabetes, Obesity & Metabolism
ISSN: 1463-1326
Popis: Aim To evaluate the efficacy and safety of ertugliflozin and sitagliptin co‐administration vs the individual agents in patients with type 2 diabetes who are inadequately controlled with metformin. Methods In this study (http://Clinicaltrials.gov NCT02099110), patients with glycated haemoglobin (HbA1c) ≥7.5% and ≤11.0% (≥58 and ≤97 mmol/mol) with metformin ≥1500 mg/d (n = 1233) were randomized to ertugliflozin 5 (E5) or 15 (E15) mg/d, sitagliptin 100 mg/d (S100) or to co‐administration of E5/S100 or E15/S100. The primary endpoint was change from baseline in HbA1c at Week 26. Results At Week 26, least squares mean HbA1c reductions from baseline were greater with E5/S100 (−1.5%) and E15/S100 (−1.5%) than with individual agents (−1.0%, −1.1% and −1.1% for E5, E15 and S100, respectively; P < .001 for all comparisons). HbA1c
Databáze: OpenAIRE